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T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. offering training, auditing, and troubleshooting expertise covering water systems, contamination control, sterilization, aseptic processing, and microbiological laboratories. He has 38 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.
Dr. Soli's career-long water systems and contamination troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about process and contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.
He is beginning his fourth 5 year term on USP Expert Committees responsible for Pharmaceutical Water, previously served 5 years on the Advisory Panel to the USP Microbiology Subcommittee, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide as well as coauthor USP's comprehensive "water bible', Chapter "Water for Pharmaceutical Purposes". As a recognized global expert in contamination and biofilm control in the pharmaceutical setting and accomplished presenter, Dr. Soli speaks at numerous conferences and webinars. He has authored numerous articles in Pharmacopeial Forum and other publications as well as chapters in books and industry guides published by PDA and ISPE.
This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.
Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.
This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:
What Makes Water Systems Have Microbial Quality Problems
Successful Sanitization Approaches for Trouble-Free Water Quality
Water System Validation by Logic Instead of Tradition
Implementing Changes to a Validated System
Reducing Water Microbial Excursions & Improving Investigations
Understanding and Controlling Endotoxin
Harmonizing vs Optimizing Water Microbial Testing for System Quality Control
Microbial Enumeration Issues with High Purity Water Systems
Water System Investigation "How-To's" and Example Case Studies
What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues
